“Perhaps no
other recent product on the market demonstrates successful health care
technology transfer better than the human papillomavirus (HPV) vaccine,
Gardasil, produced by Merck & Co. and approved by the FDA in June 2006,”
proclaimed a recent National Institutes of Health (NIH) newsletter. In a
February 23, 2007 article entitled “From Lab to Market: The HPV
Vaccine”, the NIH Record celebrated the pivotal role of
government researchers in developing Merck’s Gardasil product. “Based
largely on technology developed at NIH,” the newsletter reported, “the
vaccine works to prevent four types of the sexually transmitted HPV that
together cause 70 percent of all cervical cancer and 90 percent of
genital warts (HERE).

The occasion motivating this celebratory article was the “Philip S.
Chen, Jr. Distinguished Lecture on Innovation and Technology Transfer”
given by Douglas T. Lowy, one of the NIH scientists involved in
developing the HPV vaccine. In the ceremony pictured above, Lowy is
receiving an honorary poster from the head of NIH at the time, Elias
Zerhouni, who took advantage of the occasion to shower praise on his
team’s work, one he viewed as a model for future efforts. “It’s a
‘heroic’ story about the effort to fight cervical cancer, the second
most deadly cancer for women worldwide, said NIH director Dr. Elias
Zerhouni,” in the NIH Record’s account. “He noted that he has talked
about the vaccine’s creation to Congress and with the President on his
recent visit to NIH. How researchers took the technology ‘from the lab
to the marketplace is a journey we can learn from,’ Zerhouni said.”

While Zerhouni was bragging to anyone in Washington D.C. who would
listen about the NIH team’s role in this historic accomplishment, the
vaccine's developers were actively spreading the news of their
achievement in scientific circles. It’s hard to blame them, because at
the time Lowy and his colleague John T. Schiller, leaders of the team
that had invented the technology for the “virus-like particles” (or VLPs)
that made Gardasil possible, were in some pretty heady company. In 2008,
Harald zur Hausen, the scientist who discovered the role of human
papillomavirus (HPV) in cervical cancer during the 1980s, received one
half of the Nobel Prize in Medicine; the two researchers at the Pasteur
Institute who had discovered the human immunodeficiency virus (HIV) had
to share the other half.

Perhaps campaigning for their own place in the pantheon of medical
heroes, Lowy and Schiller described their VLP technology in several
review articles on the history and development of the Merck vaccine.
These treatments were studiously scientific in tone and at points openly
critical of their commercial partner, as the authors commented with
disapproval on the high price Merck was charging for Gardasil. But in
one May 2006 review in The Journal of Clinical Investigation,
the pair also made the following disclosure about their own commercial
interests:

“Conflict of interest: The authors, as employees of the National
Cancer Institute, NIH, are inventors of the HPV VLP vaccine technology
described in this Review. The technology has been licensed by the NIH to
the 2 companies, Merck and GlaxoSmithKline, that are developing the
commercial HPV vaccines described herein.”

Attached to an otherwise heroic narrative of the triumph of technology
over cancer, this disclosure struck a discordant note. Conflict of
interest? Inventors? Vaccine technology? Licenses? Pharmaceutical
companies? Commercial vaccines? This isn’t scientific language, but
rather the language of money and commerce. What was this unusual
concession doing there in the fine print?

This is not an idle question, for Lowy and Schiller’s conflict
disclosure forms the basis for an alternative to Zerhouni’s narrative,
one that spotlights the unusually self-contained set of Department of
Health and Human Services (DHHS) activities that surrounded HPV vaccine
development. This alternative narrative is more of a business story than
a scientific one, a narrative in which commercial interests were
inextricably linked to matters of life and death. In this narrative,
Gardasil is perhaps the leading example of a new form of unconstrained
government self-dealing, in arrangements whereby DHHS can transfer
technology to pharmaceutical partners, simultaneously both approve and
protect their partners’ technology licenses while also taking a cut of
the profits. Literally and figuratively, DHHS has the authority in such
situations to allow its business partners to get away with murder for
the greater good, effectively granting its private business partners a
license to kill.

DHHS officials have their own language for such arrangements. They call
them public-private partnerships, and DHHS agencies have gotten
progressively more aggressive about pursuing them. NIH, for example,
launched its own “Program on Public-Private Partnerships” in 2005,
shortly before Gardasil’s launch. On the web-site describing this
program, the NIH program managers concede that the kind of technology
transfer involved with Gardasil carries unavoidable ethical risks,
acknowledging that “The potential for conflict of interest exists any
time the NIH and NIH staff engage with non-Federal entities to achieve
mutual goals.” They provide little more than a pro forma solution for
such conflicts, however: any concerned NIH staffers are encouraged to
“contact their Deputy Ethics Counselor.”

It’s important to shed light on this alternative narrative as a
counterpoint to the heroic story promoted by Gardasil’s many sponsors.
An uninformed observer might like to assume that the responsible
agencies of DHHS care not at all about commercial opportunities and
exclusively attend in a disinterested fashion to the issues of health
and safety that would naturally concern any consumer of vaccine
products.

But that assumption would be incorrect. By taking a commercial
perspective on Gardasil’s development and regulation, one is forced to
confront a new and disturbing question. How is disinterested vaccine
safety governance even remotely possible when DHHS employees stand as
heroes at the head of the parade when a new vaccine is invented within
its walls, while agency leaders are leading the cheering section,
approving the new product’s launch, making the market for the product
with its recommendations and then turning around to cash multi-million
dollar checks? In order to better understand the real lessons of
Gardasil under the harsh light of the business interests at work, let’s
take a closer look at how the Merck-NIH partnership on Gardasil was
forged.Conflicts of interest in vaccine development and regulation

As the world’s largest single sponsor of biological research, NIH
frequently funds research with commercially valuable outcomes. When that
R&D generates potentially valuable inventions, NIH submits patent
applications to the U.S. Patent and Trademark Office (USPTO) and
actively pursues the approval of those patents, which when granted
become valuable commercial property for DHHS, the patents’ owner. Since
NIH has neither the authority nor the capability to pursue product
commercialization efforts, in order to encourage private companies to
invest in conducting the necessary clinical trials, NIH’s Office of
Technology Transfer (OTT) was created to grant commercial licenses for
such DHHS patents to commercial partners, including vaccine
manufacturers. When new products invented at NIH clear the requisite
regulatory hurdles at the Food and Drug Administration (FDA) and reach
the market, OTT then shares in the profits. They also distribute the
rewards back to the scientific teams whose products have succeeded in
reaching the commercial stage: when license fees flow into OTT’s
coffers, the Federal employees who invented the technology are entitled
by NIH policy to a share of the royalties.

From a technology development standpoint, such commercial arrangements
are the result of an intentional public policy; in fact they resulted
from an Act of Congress. The Bayh-Dole Act of 1980 was written with the
express purpose of making it easier for federally-funded academic
research to receive patent protection that would allow the ready
licensing of the fruits of commercially valuable R&D to private
businesses. At the time, the concern of Congress was that federally
funded inventions too often languished within the academy because
businesses had insufficient incentive to invest in clinical trials,
since these inventions were often unsupported by the powerful
competitive protection afforded by an exclusive patent license.

The policy worked. Within the research universities that receive the
vast majority of federal funding, Bayh-Dole has had the desired effect
and has enabled university technology transfer offices all over the
world to generate billions of dollars of licensing revenue in the last
few decades--especially in the life sciences--by licensing patents from
federally-funded university research to corporate partners. Bayh-Dole
has effectively turned research into big business for many universities
and transformed technology transfer offices into important profit
centers at academic institutions all over the world.

But when technology licensing takes place within federal
agencies, Bayh-Dole creates an entirely different problem: an
unprecedented web of conflict, one in which the same departments that
are tasked with regulating the health and safety of medical products are
also profiting from them. As Lowy and Schiller conceded in their review
article disclosure, this conflict of interest came into play directly on
Gardasil: both men are named inventors on the technology that makes
Gardasil possible; NIH filed for and received patents on their invention
of the VLP technology; DHHS is the owner of the patent family that
protects the commercial rights to the invention; in order to bring the
product to market, OTT licensed the vaccine technology to Merck; and as
Merck has generated billions in Gardasil revenue, OTT has received
millions in Gardasil profits.

But DHHS is also responsible for regulating Gardasil in numerous ways.
The FDA reviewed the clinical trials in which Gardasil was tested in
human populations and passed judgment on Gardasil’s safety. An Advisory
Committee on Immunization Practices (ACIP) of the Centers for Disease
Control and Prevention (CDC) decided whether or not to recommend
Gardasil for young women and children. The FDA and CDC together now
conduct the surveillance to decide whether or not Gardasil is proving
safe in larger populations. And as some families are now beginning to
seek compensation based on claims that Gardasil caused injury in some of
its recipients, the division of the Health Resources and Services
Administration (HRSA) that oversees the Vaccine Injury Compensation
Program (VICP) will soon sit in judgment as to whether, to whom, and how
much compensation will be provided to Gardasil’s victims.

As you can see in the chart below, all of this activity is supervised in
a single department by one Cabinet official, the Secretary of Health and
Human Services. The sole non-governmental agency involved in this
commercial enterprise is Merck’s Vaccine Division. In effect, the
Merck-DHHS partnership leaves the business side to Merck while DHHS is
solely responsible for

Creating the market for Gardasil by funding commercial research,
supervising the conduct of clinical trials, judging the outcome of
those trials and promoting a policy of universal vaccination;

Collecting the license fees that result from Gardasil revenues
from Merck and other vaccine manufacturers and then distributing
these financial benefits to Federal employees; and

Deciding whether or not to protect the policy decisions and
profit streams of their sister DHHS agencies through postlicensure
safety monitoring and vaccine injury compensation rulings.

Is this good government at work or an example of the medical-industrial
complex run amok? In this investigative series, Age of Autism will take
a look at how DHHS agencies have managed Gardasil in all three of these
sequences. We’ll start by taking a closer look at the NIH patent
portfolio and the associated license fees that have been flowing into
NIH coffers since 2006. (Click chart to see original slide.)

Lowy and Schiller are both employed by the National Cancer Institute
(NCI). One of the largest of the NIH institutes, NCI was established in
1937 by Franklin Delano Roosevelt. For many decades, NCI has been the
agency at the forefront of the so-called “War on Cancer.” Perhaps the
earliest inspiration for the both the Cancer War and the Gardasil
program began during the 1960s, when NCI researchers first began looking
in earnest at viruses as a potential cause for cancer. In 1961, NCI
leaders created the Laboratory of Viral Oncology to begin the search for
cancer-causing viruses; in 1962 the Human Cancer Virus Task Force was
first convened; and by the end of the decade, enthusiasm over this
research was part of the scientific momentum that persuaded President
Richard Nixon to launch the War on Cancer in 1971. Unfortunately for
Nixon’s legacy, and for most subsequent cancer victims, the War on
Cancer has famously failed to find a cure for cancer or to validate
theories of viral causation in the vast majority of human cancers.

But starting in the 1980s, the two exceptions to this litany of
failure—hepatitis B virus and the human papillomavirus--led to the
launch of two blockbuster new vaccine products. The infant hepatitis B
vaccine was developed in the 1980s and launched in 1991 with an ACIP
recommendation that all American infants be vaccinated on the first day
of life. And after 1984, when Harald zur Hausen first pinpointed the
role of certain strains of human papillomavirus in cervical cancer, the
work on another anti-cancer vaccine could begin. By the early 1990s,
laboratories all over the world were racing to develop the first HPV
vaccine.

Lowy and Schiller’s NCI team were among the four most active research
teams in this race, all of whom were aggressively filing patents on
their HPV inventions. Along with a third NCI colleague, Reinhard
Kirnbauer, Lowy and Schiller filed their first application for a patent
entitled “Self-assembling recombinant papillomavirus capsid proteins” on
September 3, 1992. Since then--and after splitting the original
application into 29 “children” in the form of numerous “divisionals”,
“continuations” and “continuations-in-part”--nine patents from that
family have been granted, as well as four from a branch of the family
tree entitled “chimeric papillomavirus-like particles.” The ability of
the novel “L1 proteins” described in their patent to “self-assemble”
into virus-like structures, which when deployed in a vaccine solution
could stimulate a protective immune response against HPV, formed the
essence of their invention. Although OTT doesn’t specify the
royalty-bearing patents, the commercially valuable technology that Merck
has licensed likely comes from this group of nine “self-assembling
recombinant papillomavirus capsid proteins” patents: US5437951,
US5709996, US5716620, US5744142, US5756284, US5871998, US5985610,
US7220419, and US7361356.

The NCI team was among the leaders in HPV technology, but the race to
make a commercially viable HPV vaccine involved several other research
teams from all over the world. Most notable among these were the
University of Queensland in Australia, Georgetown University and the
University of Rochester. In addition to NCI’s filings, each of these
university-based research teams filed their own patents; eventually,
Merck and GSK got into the act as well. Like many promising areas of
technology, the HPV patent landscape became large and crowded in a short
period of time.

Amid this blizzard of activity, the USPTO’s Bureau of Patent Appeals and
Interferences (BPAI) had to step in to sort out whether these competing
patent applications interfered with each other and to distribute the
credit, making a series of hotly contested decisions that were
ultimately appealed to the Court of Appeals for the Federal Circuit (CAFC),
the nation’s most powerful patent court. By 2007, all the BPAI and CAFC
rulings had come in and the respective contributions of all four groups
were conclusively allocated for commercial purposes. The team led by Ian
Frazer at the University of Queensland received credit for the being the
first to propose the idea of using VLP technology for a vaccine, since
their application was filed on July 20, 1992, just six weeks earlier
than the NCI team’s. But thanks to their unique technology of
“self-assembly,” most of the invention claims of the NCI patent family
remained intact as well; Lowy and Schiller’s invention has since been
generally accepted as a critical advance in the wave of new technology
that made Gardasil possible. In terms of the distribution of financial
reward, both Rochester and Queensland have reported receiving royalty
income for their HPV inventions (in undisclosed amounts) in addition to
the revenues reported by OTT.

As the technology transfer officials at OTT were paving the way for the
financial benefits from Gardasil to flow back to NIH, Lowy and Schiller
were benefiting in other ways as well, especially when it came to
scientific credit. Throughout much of 2006 and 2007, they received
awards from many quarters for their role in developing Gardasil’s
“virus-like particles.” Their joint awards included the Dorothy P.
Landon-AACR Prize for Translational Cancer Research in April 2007
and the 2007 Novartis Prize for Clinical Immunology. In
addition, Lowy by himself received the Daniel Nathans Memorial Award
in September 2007 and the American Cancer Society’s Medal of Honor
for Basic Research in October 2007.

In addition to these awards, on September 19, 2007, Lowy and Schiller
received what was perhaps their crowning honor. That’s when the
Partnership for Public Service awarded the pair the “Federal
Employees of the Year Service to America Medal.” According to its
sponsors, “The Service to America Medals have earned a
reputation as one of the most prestigious awards dedicated to
celebrating America’s civil servants. Often referred to as the 'Oscars'
of government service," they are more commonly known in government
circles as the “Sammies.” Upon receiving his crowning honor, Lowy was
interviewed for the NIH Record and professed the requisite
modesty in its October 2007 edition, saying “We are simply symbols of
the many people who have made critical contributions to understanding
the relationship between papillomavirus infection and cervical cancer.”

If Lowy was modest, the top brass at NIH could barely conceal their
pride over their employees’ accomplishments. According to the
Partnership for Public Service, “Lowy and Schiller’s 20-year partnership
has been a boon to the nation’s health and for the advancement of
scientific discovery.”

Alongside the science and policy celebrations, the business
side of the Merck-NIH partnership proceeded with a bit less fanfare and
with a different kind of currency. Once their patent was approved, OTT
could then turn to extracting their share of the benefits from their
commercial partners’ new products, which in the case of HPV vaccine
included sales first from Merck’s Gardasil product and later from
GlaxoSmithKline’s Cervarix. Merck reached the market first in 2006, but
GSK followed shortly thereafter in 2007. As each company began
collecting revenue from their new vaccines, OTT began collecting
royalties. The table below shows Age of Autism’s analysis of how Merck
and GSK’s revenues may have flowed into OTT’s coffers.

Gardasil Revenue ($M)

Cervarix revenue ($M)

NIH Top 20 Revenues ($M)

HPV Rank in NIH Top 20

HPV Revenue: estimated at 1% license fee ($M)

2006

235

--

NA

NR

2007

1,481

20

71 (est)

#4

15

2008

1,403

229

77.4

#2

16

2009

1,108

292

75.7

#1

14

Both Merck and GSK itemize revenue for Gardasil and Cervarix in their
quarterly and annual earnings statements. Their annual results are
summarized in the first two columns of the table. For Merck, Gardasil
has been a blockbuster success, yielding a cumulative total of over $4
billion in revenue through year end 2009. By contrast, GSK’s revenues
have been growing more slowly and have not yet reached a cumulative
total of half a billion dollars.

For their part, OTT does not itemize their HPV license revenues.
However, they do report their total royalty revenue as well as the
cumulative revenue from their “top 20” technology licenses since 2007.
These top 20 licenses have been worth over $70 million annually in
profits for NIH in the last three years, and HPV licenses have soared to
the top of those rankings quickly. Last year, OTT reported that HPV
licensing was its top revenue generator. OTT doesn’t disclose exactly
how much the Gardasil and Cervarix royalties contribute to NIH, but if
we make the assumption that their patent licenses entitle them to 1% of
the HPV vaccine revenues of their partners (an assumption that appears
reasonable based on the available data), then we can safely estimate
that OTT has been collecting somewhere in the range of $15 million per
year from Lowy and Schiller’s invention.

In addition to their numerous scientific awards for their discoveries,
Lowy and Schiller have received cash distributions from NIH based on
their patents. As Federal employees, they are each eligible to receive a
share of patent royalties up to $150,000 per year and Gardasil’s success
has guaranteed that they would receive the maximum reward. That means
that since FDA’s approval in 2006, each man has earned roughly a half
million dollars in royalty revenue.

* * *
This is the DHHS vision of public private partnership at work. Contrary
to the rhetoric, these partnerships aren’t simply a high-minded
collaboration of scientific visionaries, but rather a large commercial
enterprise with extraordinary profits at stake: an enterprise from which
NIH receives credit and money and based on which its corporate partners
build multi-billion dollar businesses.

How does such a partnership affect the incentives of regulators whose
job it is to make sure the products are safe? It’s not obvious that they
do. Just because DHHS has a financial stake in Gardasil doesn’t
necessarily mean that every subsequent decision its employees make is
corrupt, part of some nefarious conspiracy to kill young women for
money. Indeed, HPV royalty revenues of $15 million represent just a
small fraction of a DHHS budget that rose to well over $700 billion in
2009. In the larger scheme of things, DHHS revenues on Gardasil are just
a small drop in a very large bucket.

Far more likely to play a role, however, in public-private paternerships
like the Gardasil vaccine are the insidious cultural pressures that
emerge in a supremely political organization like DHHS. Can we really
expect the Secretary of HHS to take his or her FDA Director to task for
implementing lax standards on vaccine approval when the Director of NIH
is simultaneously praising the “heroic” researchers who invented the
product in the first place? Is it more likely that CDC will apply extra
caution in their vaccine policy recommendations when its sister agency
is involved or will they be more likely to activate the fast track in
their process of making recommendations for Gardasil? What we have
observed so far merely suggests the potential for bias in the
regulation of products in which DHHS holds a direct stake. In the next
part of our series, Age of Autism will investigate the question of
whether or not there have been actual patterns of bias in the
ways in which regulators at FDA and CDC have conducted their duties with
respect to Gardasil.
--

In the first part of this report
(HERE), Age of Autism identified a pattern of conflict of interest
at the Department of Health and Human Services (DHHS) involving Merck’s
Gardasil vaccine. Researchers at the National Cancer Institute (NCI)
invented critical technology for the “virus-like particles” (or VLPs)
that were used in the Gardasil vaccine. As the invention reached the
commercial marketplace, these researchers’ bosses at the National
Institutes for Health (NIH) celebrated their work as “heroic” and “a
journey we can learn from.” Meanwhile, officials in the NIH Office for
Technology Transfer (OTT) filed for patents on the VLP technology
invented at NCI, licensed those patent rights to vaccine manufacturers
and eventually received royalties from Merck, Gardasil’s manufacturer,
and GlaxoSmithKline (GSK).

In the second part of the series, Age of Autism will follow the
Merck-DHHS “public-private partnership” as it moved beyond NIH to its
sister agencies. In a subsequent process at the Food and Drug
Administration (FDA), officials in the Center for Biologics Evaluation
and Research (CBER) supervised the clinical trials and granted Merck the
first “Biologics License Application” (BLA) for a human papillomavirus
(HPV) vaccine. Three weeks later, the Advisory Committee on Immunization
Practices (ACIP) of the Centers for Disease Control and Prevention (CDC)
recommended universal HPV vaccination for women from nine to twenty-six
years of age, guaranteeing in one series of votes that Gardasil would
reach blockbuster status for Merck: annual revenues of well over $1
billion. Subsequently, agencies within FDA and CDC have been responsible
for monitoring Gardasil’s safety in the field, as officials within the
Health Resources Services Administration (HRSA) brace themselves to sit
in judgment over a new wave of vaccine injury claims. As we pointed out
in the first part of this series, this conflict of interest is both
extraordinary in scope and poorly understood by the general public.

At the same time, simply observing the possibility of conflict
between the commercial activities of NIH and the regulatory roles of
other agencies doesn’t necessarily mean that there will be bias,
negligence or lack of diligence on the part of DHHS regulators.
Nevertheless, the proclamation of great victory for a vaccine against
cervical cancer—one that prompted the NIH Director to single out the
invention for praise to both Congress and the President and won its
inventors recognition as Federal Employees of the Year—could certainly
have created pressure to usher Gardasil through the BLA approval and
ACIP recommendation processes with special attention and unusual
dispatch. As a result, one might argue that the potential for
bias on the part of CBER and ACIP regulators--regulators who would have
had a dangerous temptation to relax their required skepticism and hold
the favored new product to lower standards of safety—gave them a
responsibility for unusual diligence and extra care. But what does the
evidence really say about their actual level of diligence? Did
CBER and ACIP officials betray their eagerness to enable the celebration
of a new “anti-cancer vaccine” or did they hold Gardasil to even more
exacting standards of safety? Let’s take a closer look at how FDA and
CDC approached their respective responsibilities for Gardasil.

When the FDA issued its approval of Merck’s BLA for Gardasil on June
8, 2006, its decision was based on a review of Merck’s data from five
separate clinical trials, each of which included efficacy and safety
assessments for Gardasil. Four of the five trials approached their
efficacy and safety studies in similar fashion, comparing Gardasil
against a “placebo” that contained an active ingredient, with one trial
comparing Gardasil against what the CBER reviewers described as a
“saline placebo.” All together, these five trials examined a total of
close 12,000 subjects who received at least one dose of Gardasil and
compared their outcomes to roughly 10,000 subjects who received up to
three injections of what Merck and CBER officials agreed to describe as
a “placebo.”

But what is a placebo, really? One definition describes a placebo as
“an innocuous or inert medication; given as a pacifier or to the control
group in experiments on the efficacy of a drug.” The operative term here
is the word inert. But in four of the five trials, Gardasil
placebos contained a substance called an adjuvant, “a substance
which enhances the body's immune response to an antigen.” According to
one of the trial publications, most of the Gardasil trial placebos
actually contained an “amorphous aluminium hydroxyphosphate sulfate
adjuvant… and was visually indistinguishable from vaccine.” So
although the majority of the placebo treatments in the Gardasil trials
did not include Gardasil VLPs, they were by no means inert. In control
populations representing nearly 95% of all “placebo” recipients, the
study subjects received a formulation that actually included an
immunologically active (and potentially harmful) aluminum adjuvant.

One of the five trials, however, was different. In this trial, the
only one that examined a younger population of nine-to-fifteen year
olds, the placebo recipients did not receive an aluminum adjuvant. By
contrast, and according to most of the FDA documentation, the nearly 600
control subjects in this trial received a formulation most commonly
described as either a “non-alum placebo” or a “saline placebo.” The
safety results of this trial deserve special notice, since it’s the only
trial that compared Gardasil to a solution that could reasonably be
described as “inert.”

But even that assumption would overstate the case. Although the
“saline placebo” did contain water and sodium chloride (ordinary table
salt), the FDA was incorrect to suggest that there were no other active
ingredients. According to the published description of this trial’s
methods, “The placebo used in this study contained identical
components to those in the vaccine, with the exception of HPV L1 VLPs
and aluminum adjuvant, in a total carrier volume of 0.5 mL.”
Formulations like this, which are made up of everything in the vaccine
except its immunologically active components, are sometimes called a
“carrier solution.” The correct description of the placebo as a “carrier
solution” rather than a “saline placebo” was provided only once in the
CBER review, buried in a table on page 301. Nowhere in either the CBER
review or the published account of the trial can one find any
description of this placebo’s ingredients.

It is possible, however, to infer the composition of the carrier
solution from Merck’s Gardasil package insert, which lists the vaccine’s
immunologically inactive ingredients. These include: “yeast protein,
sodium chloride [table salt], L-histidine [an amino acid], polysorbate
80 [an emulsifier], sodium borate, and water for injection.” At least
one of these chemicals, sodium borate, is a chemically reactive toxin,
one that has many industrial uses as an active ingredient. These include
applications as: a replacement for mercury in gold mining; an
insecticide and fungicide; and a food additive that is now banned in the
United States.

Is there any defense for the FDA to allow this approach to placebo
selection in the Gardasil trials? From an efficacy standpoint, one can
reasonably argue that yes, using an adjuvant in a placebo makes sense,
since it will provide the most rigorous test of the value of the active
ingredient under review, in this case the VLPs invented at NCI. And in
fact, the returns from all five clinical trials provided convincing
evidence that when the VLPs were added to a vaccine formulation
containing the aluminum adjuvant, a strong immune response resulted.
CBER therefore drew the reasonable conclusion that Gardasil works, at
least against the endpoints it was able to measure.

But is it safe? When it comes to the accurate measurement of adverse
effects of Gardasil, there is little justification for reliance on a
placebo with ingredients that are not inert. There is some limited
value, perhaps, in comparing adverse events that are introduced solely
by the addition of VLPs to the vaccine solution. But a truly rigorous
safety assessment would investigate the full safety profile of the VLPs
in combination with the aluminum adjuvant and compare that
profile to the profile of an inert solution. After all, the adjuvant is
present precisely because it is not inert.

If the FDA trial standards were truly to enforce a high standard of
safety, they would require the comparison of Gardasil’s safety profile
to a true saline placebo. But Merck performed no such analysis and CBER
permitted them to apply a lesser safety standard of safety analysis. As
a result, CBER issued its BLA approval without any idea whatsoever of
the true risks of Gardasil. Not surprisingly, most of the comparisons
between adverse outcomes for those receiving doses of Gardasil and those
exposed to an aluminum adjuvant “placebo” showed little evidence of
injury risk from Gardasil.

Unfortunately, the conclusion that Gardasil was therefore safe was
horribly wrong.

Based on the data provided in CBER’s review of the Gardasil trials,
it is possible to piece together an alternative view of Gardasil’s
adverse event profile by examining three separate populations: 1) the
subjects who received actual doses of Gardasil (over 96% got all three
doses); 2) the subjects who received a “placebo” containing an aluminum
adjuvant (over 98% got 225 micrograms of amorphous aluminum hydroxide
sulfate) formulated in a carrier solution that made it visually
indistinguishable from the full vaccine; and 3) the subjects who
received only doses of a carrier solution. For the Gardasil and aluminum
adjuvant groups, safety results were collected in two ways: a smaller
set of reported outcomes was measured for the entire trial group (the
“general safety population”) and a smaller group (the “detailed safety
population”), including the entire carrier solution group, followed a
more detailed protocol. The respective sizes of these safety assessment
groups are shown below. Unfortunately, the small relative size and
somewhat unmatched profile of the carrier solution group reduces the
statistical power of a comparative analysis across the three groups: the
age profile of this carrier solution trial was younger (9-15 years of
age) than the other four trials (10-26 years of age, with the bulk
falling between 16-23 years old); and less female (54%) than the
Gardasil recipients (over 90%) and the aluminum adjuvant recipients
(100% female). Nevertheless, the results of this three way comparison
are the closest thing we have to a valid, non-passive safety analysis;
and they show striking differences in safety profiles, none of which can
be attributed to sample bias.

There are several ways in which the CBER trial review permits a
comparative safety analysis across all three groups. The first is by
comparing immediate adverse events at the injection site: events such as
pain, swelling, “erythema” (redness of the skin), hemorrhage and
pruritis (itching). These events are highly specific and show up in the
first few days; they can, however, vary quite a bit in terms of
severity. The Gardasil trials reported their results for these injection
site adverse events in the “detailed study population” within five days
after any vaccination visit. The comparison of these outcomes is shown
below (using a scale that keeps the ratios between the rates of the
adverse events constant).

As the chart shows, the vast majority of the Gardasil (81%) and aluminum
adjuvant (75%) groups reported some kind of adverse event, most of which
involved some kind of pain. By contrast, less than half of the carrier
solution group (45%) reported an adverse event. This pattern continues
in almost all of the individual categories, with the Gardasil group
showing the largest rate of local reactions, followed closely by the
aluminum adjuvant group and then with a clear drop off in the frequency
of adverse events in the carrier solution group. On a retrospective
basis, all but one of the reduced risks for the carrier solution group
were statistically significant.

The most striking difference between the three groups is in the area
of “serious adverse events.” Although less frequent than minor instances
of pain or swelling at the injection site, these serious events were
disturbingly common in the groups exposed to active substances. Nearly
5% of the Gardasil recipients had a serious adverse event, well over six
times the rate of the carrier solution group. And more than 2% of the
aluminum “placebo” recipients had severe reactions, more than three
times the rate of adverse events in the carrier solution group. Based on
this finding alone, it’s hard to defend the choice to classify Merck’s
adjuvant as an “inert” placebo.

A second approach to comparative safety analysis involves examining
the adverse events that caused the participants to withdraw from the
trial in a two week period after any vaccine visit. These withdrawals
included a range of adverse reactions, only a small fraction of which
the investigators designated as “severe.” But sudden deaths (which need
not be specific to the vaccine) were also included. The comparison of
the discontinuation rates in the three groups is shown below.

Overall, the rate of discontinuation was low, at less than half a
percent. But in the carrier solution group not a single recipient chose
to drop out of the trial. In addition, there were three discontinuations
after two weeks due to deaths in the Gardasil group and one such death
in the aluminum adjuvant groups, whereas there were zero deaths at any
point in the carrier solution group. Seven discontinuations (four in the
Gardasil group and three in the aluminum adjuvant group) were due to
other severe adverse events. These are obviously small numbers, and the
deaths were dismissed by the reviewers as unrelated to vaccination. And
in fact, the rate of discontinuation in the Gardasil and aluminum
adjuvant groups was nearly identical. As a result of this similarity on
outcomes, the CBER reviewers dismissed any effect of vaccination on
withdrawal decisions, in all likelihood because the vast majority of the
officially designated “placebo” group was exposed to the aluminum
adjuvant.

A third approach to a comparative safety analysis takes a longer view
of adverse events, using data for serious adverse events over a twelve
month period after the beginning of the trial. The FDA review includes
voluminous data on these events, but one of the easiest to measure is
simply the overall rate of serious adverse events. The trial data show
rates for such serious events that were similar between the Gardasil and
placebo group. Indeed the rate of serious adverse events in the Gardasil
group (1%) was actually lower than the placebo group as a whole (1.1%).
Not surprisingly, however, this result was driven entirely by a high
rate of serious adverse events in the aluminum adjuvant group. When one
examines the rate of serious adverse events in two distinct placebo
groups, the rate of serious adverse events in the aluminum adjuvant
group rises even higher, to 1.27%, while the rate in the carrier
solution group comes out at zero. This comparison is shown below.

A final approach to safety assessment takes the extensive twelve-month
data on the medical conditions in all trial subjects and examines the
longer term adverse events in specific categories of interest. Several
such categories show disturbing patterns. Autoimmune conditions like
arthritis, lupus and thyroiditis were sharply higher in the Gardasil
group when compared to the overall “placebo” group and were even noted
by the FDA reviewer as a source of concern. These occurred at a rate of
over 1 in 1000 in the Gardasil group; there were, however, zero reported
cases of autoimmune disorders in the carrier solution group. As in the
two week analysis, death rates over twelve months were higher in the
Gardasil and aluminum groups. By contrast, the carrier solution group
had no deaths in the longer period. The chart below shows the results
for the twelve month analysis.

How much of the low rate of adverse events in the carrier solution group
(officially designated the “018 Protocol”) was due not to real
differences in outcome but rather to sample bias, the fact that the
population for the 018 Protocol was younger and less purely female than
the other four trial populations? The short answer is, not very much.
There are several ways to test the effect of sample bias. These include:
comparing the adverse event rate in the 018 Gardasil group to the
Gardasil groups in the other four protocols (higher adverse events show
the 018 population was morevulnerable); comparing
differences in adverse event rates between boys and girls in the 018
Gardasil group (higher adverse events in boys also show the 018
population was morevulnerable); and comparing
differences in rates between the 9-12 year olds and the 13-15 year olds
in the 018 Gardasil groups (higher adverse events in younger subjects
show the 018 group was more vulnerable). If anything, most of
these comparisons suggest the use of the carrier solution group
understates the adverse event rate for Gardasil. For example, the
younger subjects in both 018 groups had a higher rate of injection site
adverse events and the 018 Gardasil group also had a higher rate of
severe adverse events than the other groups. Only the findings on deaths
and discontinuations (which were most frequent in the Protocol 018
Gardasil boys and 13-15 year olds) might have been influenced by sample
bias.

When it came to the most serious adverse event of all, death, the FDA
review effectively gave Gardasil a free pass. They failed to mention, of
course, that the deaths in their “placebo” group actually received the
entirety of the vaccine’s contents excepting the VLPs. Nevertheless,
they did report briefly on each individual case of death. In cases of
death due to traumatic events like motor vehicle accidents, however, no
details were reported (could a seizure or heart attack while driving
have caused some traumatic events?). In most of the biologically-related
deaths, they found reasons not to make any connection to Gardasil or to
blame the victims’ behavior (“they were on birth control pills”) or
family history (“the family had a history of arrhythmia”). Here is the
FDA reviewer’s summary of the deaths in the trial.

There were 10 deaths in the Gardasil recipients (0.8%), and 7
deaths in the placebo group (0.7%). The majority of the deaths were due
to trauma in both groups. These deaths did not appear related to vaccine
administration.

In each treatment group, there was a death related to a deep vein
thrombosis and/or pulmonary embolism, and both subjects were on hormonal
contraceptives. The Gardasil recipient with this event had symptoms of
leg pain prior to the first vaccination. The other Gardasil recipients
who died included one subject with pancreatic cancer 578 days after dose
3, and one young male who died of arrhythmia 27 days after dose 1. This
latter subject had a strong family history for arrhythmia. These events
did not appear related to administration of the vaccine.

Even if all of these deaths could be explained away one way or
another, this certainly sounds like a lot of deaths for such a young,
and overwhelmingly female, group (16 of the 17 deaths were in females;
one 15 year-old male Gardasil recipient died of a heart attack). What
kind of death rate is normal for young women? The trials provide no such
reference rate, but such statistics are readily available. Carnegie
Mellon has a web-site called “Death Risk Rankings” (see
HERE) that provides an interactive tool for calculating death rates
within a wide range of demographic categories. For American females in
the age range of the Gardasil trials (9-26 years of age), the rates are
as follows: 2.75 per 10,000 in 10-19 year olds and 5.03 per 10,000 in
20-29 year olds. [Note: the majority of trial subjects were from the
U.S. and Europe. European deaths rates from young women are 30% lower
than American death rates, making this a conservative comparison].

Out of 11,778 Gardasil recipients, over 90% of them young women
between the ages of 9 and 23, one would expect an annual death rate to
be a mix of the rates for the two reference groups, or less than 4 per
10,000 in an entire year. But in the trials, there were three “sudden
deaths”, i.e. deaths that occurred within just the two weeks of the
Gardasil injections, in a review period of less than forty-five days.
That’s a death rate close to ten times higher than would be expected
such a short period. And the overall Gardasil death rate of 8.5 per
10,000 (10 deaths out of 11,778) for the 12 month period of the trial is
more than twice what one would expect. The FDA review evinced little
concern over this high death rate, preferring instead to compare the
deaths in the Gardasil group to that of the “placebo” group. But as one
can see from the chart below, the death rate in the aluminum adjuvant
group was higher than the reference groups as well.

In short, the CBER review of Gardasil condoned the use of an
immunologically active placebo and not an inert solution. So instead of
a adopting an increased measure of diligence in light of the potential
for bias due to the DHHS conflict of interest in Gardasil, it appears
that FDA permitted Merck to use a lower standard of safety. Only by
using the single set of trial data in which the placebo solution was
relatively (although not entirely) inert, can one assess the impact of
this relaxed standard. Based on an analysis of this data, one is drawn
to an inescapable conclusion.

If the FDA was less than diligent in its review of safety profile of
the anti-cancer vaccine invented at its sister agency at NIH, how did
its counterparts at CDC compare in terms of their own decision
processes? Faced with a choice either to take a deliberate course,
allowing a period of observation to follow Gardasil’s BLA approval, or
to rush Gardasil into widespread use, CDC’s approach provides another
standard of comparison for DHHS’s conduct. Would their key
decision-making group, the Advisory Committee on Immunization Practices
(ACIP) choose the deliberate or the hasty path?

There is very little ambiguity in this answer. ACIP wasted absolutely
no time in recommending Gardasil for universal use among young women.
Indeed, it would have been hard for them to move any faster. In June
2006, almost immediately after FDA approval, ACIP recommended the HPV
vaccination. An account in the March 23, 2007 edition of the CDC
publication, Morbidity and Mortality Weekly Report (MMWR)
showed that ACIP was preparing for near instantaneous approval even
before the FDA’s final reviews were completed.

The Advisory Committee on Immunization Practices (ACIP) HPV
vaccine workgroup first met in February 2004 to begin reviewing data
related to the quadrivalent HPV vaccine. The workgroup held monthly
teleconferences and meetings three times a year to review published and
unpublished data from the HPV vaccine clinical trials, including data on
safety, immunogenicity, and efficacy. Data on epidemiology and natural
history of HPV, vaccine acceptability, and sexual behavior in the United
States also were reviewed. Several economic and cost effectiveness
analyses were considered. Presentations on these topics were made to
ACIP during meetings in June 2005, October 2005, and February 2006.
Recommendation options were developed and discussed by the ACIP HPV
vaccine workgroup. When evidence was lacking, the recommendations
incorporated expert opinion of the workgroup members. Options being
considered by the workgroup were presented to ACIP in February 2006. The
final recommendations were presented to ACIP at the June 2006 ACIP
meeting. After discussions, minor modifications were made and the
recommendations were approved at the June 2006 meeting.

The date of the BLA approval for Gardasil was June 6, 2006. In the
June 29 ACIP meeting, just 23 days after the FDA’s decision, ACIP gave
Gardasil its formal support. The vote was unanimous, with two of the
fifteen members abstaining due to their financial involvements with
Merck.

But not only was the vote unanimous, the mood in the meeting was
celebratory. Numerous vaccine safety advocates attended the June meeting
due to their concerns over the influenza vaccines. One attendee
recounted the reaction to the Gardasil decision. “After the vote the
place erupted in applause. There was hand-shaking and back-slapping. It
seemed kind of odd and inappropriate to us.” Asked why it seemed
inappropriate, the observer explained that the concern arose, “because
they were so clearly cheering the recommendation. It was clear and
absolutely a celebratory reaction.”

The safety discussion was almost exclusively informed, of course, by
the FDA’s flawed trial data. Not surprisingly, few concerns were raised.
Here’s what the ACIP minutes had to say about Gardasil’s safety profile.

The clinical trial program places strong emphasis on evaluating
the safety profile of GARDASIL®. Of ~21,464 subjects, ~11,000 received
detailed safety follow-up and the remainder received serious adverse
experiences in medical history and pregnancy follow-up. The incidence of
overall adverse events (AEs), injection-site AEs, and low-grade fevers
>100°F was slightly higher in the GARDASIL® group compared to the
placebo group. Systemic AEs were comparable between the two groups.
Serious AEs and discontinuation due to adverse experiences were
extremely rare. [emphasis added]

As a result of this accelerated process, ACIP made a series of
recommendations. The first placed Gardasil on the recommended list of
childhood vaccines. “ACIP recommends routine vaccination of females
11-12 years of age, with three doses of the quadrivalent HPV vaccine.
The vaccine series can be started as young as nine years of age at the
discretion of the provider.” In the context of the clinical trials, this
was an extremely aggressive recommendation. A scant 85 pre-pubescent
girls, nine years of age or younger had received Gardasil in any trial
(matched with only 48 controls) and only three percent of the Gardasil
trail recipients were in the range of ACIP’s target population of 11-12
year olds. Not only was ACIP basing its recommendation on flawed safety
analysis, it was extending its recommendations to include groups who lay
outside of even this biased assessment.

But ACIP didn’t stop there. They also recommended a catch-up vaccine
for all young women, even those who would have been sexually active for
many years, who had contracted at least one strain of the virus, cleared
it, and therefore received diminished benefit from vaccination. “ACIP
recommends vaccination for females 13-26 years of age who have not been
previously vaccinated. Ideally, vaccine should be administered before
onset of sexual activity, but females who are sexually active should
still be vaccinated.” From a commercial perspective, this
recommendation multiplied Gardasil’s profit potential for Merck and its
NIH partners, creating a near term target market that was seven times
larger than just the routine market of 11-12 year- olds.

There was little effective restriction placed on Gardasil’s market
potential. And only the yeast protein in the carrier solution was cited
as a safety concern. “Vaccination should be deferred until after
moderate or severe acute illnesses improve,” read the ACIP
recommendation. “A history of hypersensitivity or severe allergic
reaction to yeast or any other vaccine component should be classified as
a contraindication. Initiation of the vaccine series should be delayed
until after completion of the pregnancy.”

The momentum for an aggressive roll-out was strong. Representatives
from nine different organizations gave formal statements in support of
Gardasil during the public comment period. In the meantime, and with a
strong push from Merck, some state officials stood in line to move even
faster than ACIP. In February of 2007, Republican Texas Gov. Rick Perry
bypassed the legislature and mandated Gardasil for all 11- and
12-year-old girls in the state.

The commercial results were powerful and immediate. Merck reported
its first revenues from Gardasil in the second quarter of 2006
(presumably from sales after the June BLA approval), and its revenues
began to climb rapidly: $70 million in the third quarter, $155 million
in the fourth quarter, all leading to a blockbuster year of 2007 in
which Gardasil recorded revenues of $1.5 billion. The financial bonanza
had begun in earnest.

A few years later, Merck would attract criticism for its aggressive
marketing of Gardasil during this period. Sheila and David Rothman wrote
a sharp critique in the Journal of the American Medical Association
(hardly a radical hotbed of vaccine consumerism) in which they neglected
the conflicts described here but noted the extreme measures that Merck
adopted.

The marketing of this vaccine broke with traditional practices.
Heretofore, vaccines had been identified by the disease they were
preventing (measles, mumps) or by their creators (Salk or Sabin). This
HPV vaccine followed a different model. It was identified by a trade
name, Gardasil, and promoted primarily to “guard” not against HPV
viruses or sexually transmitted diseases but against cervical cancer.
The marketing campaign that followed, according to Merck’s chief
executive officer, proceeded “flawlessly.” In 2006, Gardasil was named
the pharmaceutical “brand of the year” for building “a market out of
thin air.”

But the Rothmans’ critique would do little to delay or disrupt the
launch. At the time of the DHHS rush to market there were few dissenting
voices and none of them were heard at ACIP.

One lone voice stood out. In March 2007, just as the vaccine was
reaching its peak revenue numbers, one of the doctors who had guided the
clinical trials voiced an objection. On March 14, 2007, an article in a
small newspaper in Fort Wayne, Indiana reported on an interview with one
of the scientists involved in the clinical trials. The scientist was
named Diane Harper and she expressed dismay at the ACIP recommendation.

"Giving it to 11-year-olds is a great big public health
experiment," said Diane M. Harper, who is a scientist, physician,
professor and the director of the Gynecologic Cancer Prevention Research
Group at the Norris Cotton Cancer Center at Dartmouth Medical School in
New Hampshire.

"It is silly to mandate vaccination of 11- to 12-year-old girls
There also is not enough evidence gathered on side effects to know that
safety is not an issue."

Harper didn’t have much to gain from the commercial success of
Gardasil, but she also was taking considerable risks by breaking ranks
with her colleagues. One can only imagine how things would have been
different if she had been in charge of the review process at FDA rather
than running one branch of the clinical trial. In the midst of such a
widespread degradation in regulatory ethics and standards, it’s
interesting to consider why she made that choice.

The Fort Wayne reporter, Cindy Bevington, was frank as to why Harper
was telling her story to them rather than a larger media outlet. “For
months, Harper said, she's been trying to convince major television and
print media to listen to her and tell the facts about the usefulness and
effectiveness of this vaccine.” Why was an inside critique of the
Gardasil promotion campaign not already big news? "No one will print
it," Harper said.

Over the coming months, the assessment of adverse effects of Gardasil
would be transferred to a different group within DHHS, from CBER and
ACIP to the “postlicensure safety surveillance” groups within FDA and
CDC. At this point, the deaths and serious adverse events would leave
the realm of closely held statistics within a vaccine manufacturer’s
actively monitored trial sample and into the realm of passive
surveillance in the general population; soon watchdog and vaccine safety
groups like National Vaccine Information Center and Judicial Watch
issued critical analyses, see
HERE and
HERE. And Harper’s concerns over the inadequate safety data would
prove prophetic. Why had Harper broken ranks so early? When Bevington
asked Harper why she was speaking out despite the momentum to the
contrary, her answer was refreshingly simple.

In parts 1
(HERE) and 2
(HERE) of this series, Age of Autism identified a disturbing pattern
of conflicts within the Department of Health and Human Services (DHHS)
regarding Merck’s Gardasil vaccine. In an unprecedented “public-private
partnership,” researchers at the National Institutes of Health (NIH)
patented the technology for the “virus-like particles” (VLPs) that
provoke Gardasil’s immune response to the human papillomavirus (HPV) and
licensed their VLP technology to Merck. The terms of the patent license
effectively made DHHS Merck’s financial partner on Gardasil, giving DHHS
a clear conflict of interest on decisions regarding Gardasil.

This
partnership gave Gardasil favorable treatment at key decision points,
treatment that was financially rewarding to both parties. While the NIH
Director celebrated his researchers’ “heroic” achievement and the
researchers received numerous awards, including “Federal Employees of
the Year,” officials at NIH’s sister agency, the Center for Biologic
Research and Evaluation (CBER) of the Food and Drug Administration
(FDA), stood watch over the Gardasil clinical trials. CBER’s review
failed to hold Gardasil to a high standard of safety. Instead of
comparing Gardasil to an inert placebo, as they should have, CBER based
its entire safety assessment on a comparison of Gardasil’s adverse event
profile with the adverse events associated with a “placebo” that was
actually an immunologically active aluminum-based adjuvant. Despite the
fact that an alternative comparison, pitting Gardasil against a
relatively inert “carrier solution,” should have warned them of clear
evidence of harm to Gardasil recipients, CBER approved Merck’s Gardasil
Biologics License Application (BLA) anyway. In the meantime, following
CBER’s approval of Merck’s BLA a key committee at the Centers for
Disease Control and Prevention (CDC), the Advisory Committee on
Immunization Practices (ACIP), put Gardasil on a fast track and
immediately recommended three doses of the Gardasil vaccine to all
American women between nine and twenty-six years of age. In a matter of
days, Merck was guaranteed a blockbuster launch for Gardasil and within
months Gardasil had reached annual revenue levels of well over $1
billion. Soon, Gardasil would become the #1 royalty generator for NIH’s
technology licensing group, completing the partnership circle.

As a result of this favorable treatment at the hands of it regulatory
partners at DHHS, by late 2006, Merck’s Gardasil was reaching a mass
market of young American women. FDA had downplayed the fatalities
associated with Gardasil in the clinical trials, but in a population of
less than 12,000 young people, three sudden deaths following Gardasil
and ten deaths within a year were a clear cause for concern. And as
Gardasil’s reach was extending to a population numbering in the
millions, the body count would soon rise. At this point in the process,
the locus of DHHS conflict of interest would shift from agencies
responsible for prelicensing activities such as clinical trial review
and public health policy assessments to the agencies responsible for
what insiders call “postlicensure surveillance” activities. The events
the follow Gardasil’s launch is where part 3 of this series begins.

On July 20, 2008, the New York Post reported the vivid account of a
mother who claimed her daughter was killed by Gardasil. In a story
titled “My Girl Died As 'Guinea Pig' For Gardasil,” Lisa Ericzon’s
description of her daughter’s tragic death was both detailed and
disturbing. As told by the Post’s reporter, the story began like this:

“She loved SpaghettiO's, pepperoni, lilies, listening to her iPod and
making her pals laugh. In her senior yearbook, she wrote, "The best
things in life aren't things, they're friends." Now that's the quote
chiseled into her gravestone.

Jessica Ericzon, 17, was "an all-American teenager," as described
by one of her upstate LaFargeville teachers. Last February, she was
working on her softball pitches, getting ready for a class trip to
Universal Studios in Florida and hitting the slopes to snowboard with
her older brother. Then one day, the blond, blue-eyed honors student
collapsed dead in her bathroom. It started with a pain in the back of
her head.

On the advice of her family doctor, Jessie had taken a series of
three Gardasil shots.

Sadly, Jessica Ericzon’s death was not an isolated incident. Since
Gardasil’s launch in late 2006, a rising number of parents have stepped
forward to report the deaths of their daughters at the hands of the
vaccine. Gardasil has now become a global product, so these reports
have come from around the world; but the United States is by far Merck’s
largest market, so most of the reported fatalities have come from closer
to home. Jessica Ericzon came from upstate New York, about a mile south
of the Canadian border, and her parents were among the first to go
public about Gardasil. But they haven’t been the last. There are at
least ten public reports of young women allegedly killed by Gardasil in
the months since FDA approved Merck’s BLA on June 8, 2006. Many more
have been reported privately to the CDC.

In contrast to Jessica’s sudden death, and just a few weeks before the
New York Post headline and article, another family went public with
their daughter’s plight, in a blog named “Jenny’s Journey.” In their
introductory blog post, Jennifer Tetlock’s parents relayed an urgent
request. Their daughter wasn’t dead, but she was dying from what Jenny’s
doctors had theorized was a rare degenerative neurological condition, an
unusual form of early onset amyotrophic lateral sclerosis (or ALS,
popularly known as Lou Gehrig’s disease). The bloggers, Barbara Mellers,
Philip Tetlock, and Barbara Shapiro, were in no sense activists, and
weren’t eager to join what they later termed the “anti-Gardasil
movement.” What they wanted most of all was to find a way to save their
daughter’s life. “One of the major things that would help her doctors
figure out what to do”, they wrote on June 6, 2008, “is to find other
people like Jenny (called "comparables")--people that share her medical
condition and perhaps have had luck with certain treatments.”

The list
of Gardasil victims who have gone public--parents of young women like
Jessica Ericzon and Jennifer Tetlock--provides only a fragmentary view
of the death toll associated with Gardasil. Many more deaths have been
reported to the Vaccine Adverse Events Reporting System (VAERS) in cases
where the family has chosen not to go public with their tragic loss.
Among the short list of publicized cases, most simply dropped dead like
Jessica Ericzon within days of receiving a dose of the vaccine; these
cases most closely resembled the three cases of sudden death from
Gardasil reported during the clinical trials. Cases of clear
“comparables” to Jenny Tetlock, young women who could satisfy Jenny’s
parents’ quest, were less common. Nevertheless, there were a number of
these publicly reported cases in which a Gardasil shot seemed to trigger
a downward spiral of ill health-- encompassing a diverse range of
symptoms--that would culminate in death (many of which came on suddenly
as well).

The table below summarizes the connection between Gardasil and ten
deaths that have been publicly associated with the vaccine. All of these
stories have been reported elsewhere, most of them assembled in a
memorial web-site called “The Truth About Gardasil.” You can find go to
this web-site to read more about the stories of many of these young
women (see
HERE).

Name

Date of First Vaccine

Date of Death

Reported Cause, Complications and
Timing of Death

1

Santana Valdez

Dec, 2006?

Aug 31, 2007

Sudden death, with airway papillomatosis, less than 4
months after 3rd dose

Sudden death 6 months after 3rd dose after
increasing cardiac and neurological symptoms

These public reports provide varying degrees of detail regarding cause
of death. In one case (one where substantial detail has been reported),
a young woman named Brooke Petkevicius who died suddenly after her first
dose of Gardasil showed symptoms remarkably similar to a case report
detailed in CBER’s clinical trial review. The February 6, 2008 edition
of East Bay Express (see
HERE), a San Francisco Bay Area newspaper, provided the following
account.

In early 2007, as the pharmaceutical giant Merck began promoting
its new vaccine Gardasil as protection against cervical cancer, Brooke
Petkevicius was a nineteen-year-old freshman at UC Berkeley. She had
seen the ads for the vaccine, and discussed getting it with her mother,
whose gynecologist also had recommended it. On March 12, Brooke received
the first of three doses. Two weeks later, she dressed to go running
with a friend. As they reached the elevator, Brooke suddenly collapsed
against the wall and had a seizure.

"She started shaking a lot," recalled the friend, Kristin
Bietsch. "And her eyes went glazy a little bit." An ambulance rushed
Petkevicius to the hospital, but doctors couldn't save her. Her autopsy
indicated that she was killed by a pulmonary embolism, or blood clot,
which had blocked the artery between her heart and lungs. "She had a
whole bunch of little floating clots in her system," said her mother,
Debra Sonner, recalling what doctors told her at the time.

Was Brooke’s death just a random coincidence or were there clues from
the early safety reviews that anticipated her tragic death? One needn’t
look far for comparable stories: the following account comes from one of
the three sudden deaths after Gardasil reported in the clinical trials.

This 22 year old non-smoking white female subject had symptoms of
leg pain prior to the vaccination (11/15/02), and was seeing a masseur
for this complaint. She was also on hormonal contraceptives. The subject
was vaccinated with her first dose of Gardasil on -------. On --------,
Day 19 Postdose 1, the subject experienced suspected deep vein
thrombophlebitis (DVT) of the left leg and consulted her own general
practitioner. On --------, Day 20 Postdose 1, the subject experienced
severe chest pain and was taken to the emergency room (ER). The subject
subsequently experienced a suspected acute massive pulmonary embolism of
severe intensity and was admitted to the intensive care unit (ICU).
Echocardiography was performed and showed normal aorta and no thrombosis
in the vena cava. Abdominal ultrasound was performed with no abnormal
findings. On the same day, the subject died of acute massive pulmonary
embolism and deep vein thrombosis of the left leg. The autopsy report
confirmed the diagnosis of acute massive pulmonary embolism and deep
thrombophlebitis of the left leg and also revealed an incidental finding
of acute ischemic renal failure.

As this account suggests, the CBER review eventually explained away
this death as a coincidence, an unfortunate side effect of taking birth
control pills in a situation where the victim suffered from a
pre-existing condition. So as soon as reports of similar deaths began
entering the VAERS system, the CDC found ways to dismiss comparable
cases such as Brooke Petkevicius by pointing a finger at birth-control
pills as well. In a June 2007 report on the early deaths from Gardasil
that were reported to the Vaccine Adverse Event Reporting System
(VAERS), CDC dismissed Brooke’s death as yet another coincidence.
“Preliminary data indicate that the two women [including Brooke], who
died of blood clots were taking birth-control pills, and blood clots are
a known risk associated with birth-control pills. All four deaths are
being fully investigated but none appear to be caused by vaccination,"
claimed CDC. With regard to Gardasil, CDC wrote in its defense, "Since
more than 5 million doses have been distributed, some deaths will occur
coincidentally following vaccination (but not due to vaccination)."

Blaming the victim and citing coincidental death following
vaccination are two well-known tactics that long ago became part of the
DHHS playbook and CDC is not alone in deploying this tactic. In addition
to the pulmonary embolism described above, the CBER review dismissed the
two other cases of sudden death following Gardasil. One such case was a
15-year old boy who died of a heart attack less than a month after his
first dose of Gardasil; yet CBER reported “the autopsy was inconclusive,
but there was a strong family history of arrhythmia.” The other case was
a 21 year-old woman who died with a convulsion four days after her third
Gardasil dose; the CBER review again blamed this victim for her death,
reporting that “this subject had a history of seizure disorder and
anxiety. She suffered a seizure 4 days after dose 3, and was noted to
have cocaine in her urine.”

Natural skepticism aside, making sense of individual cases like the
ten public death reports and the three sudden deaths in the Gardasil
trials is tricky business. Without intensive medical investigations one
may never find definitive proof of harm from Gardasil. And, of course,
the vast majority of Gardasil recipients have survived their vaccination
series with no discernible lasting effects. There can be little dispute,
however, that Merck has an enormous incentive to downplay obstacles to a
profitable new product like Gardasil. And unfortunately, as we’ve seen
in the clinical trial cases, FDA appears to have shared Merck’s bias,
acting more like an equity participant in a DHHS “public-private
partnership” than a conscientious guardian of the public trust; Its CBER
reviewers effectively turned a blind eye to troubling signals as they
granted Merck its BLA for Gardasil. Inevitably, however, a persuasive
critique of vaccine safety monitoring for a blockbuster vaccine like
Gardasil needs to move away from the realm of anecdote and into the
realm of statistics. As we move beyond the review of individual cases,
we’ll take a closer look at whether or not DHHS officials displayed
notable biases in their analyses of Gardasil’s adverse effects in larger
populations and how those analyses have been criticized by others.

Responsibility for what public health officials call “postlicensure
safety surveillance” falls to a small set of DHHS departments. Two of
these are the FDA’s Vaccine Safety Branch (VSB) and the CDC’s
Immunization Safety Office (ISO). After CBER approves a vaccine and ACIP
recommends it, the baton within DHHS passes next to VSB and ISO. In the
passing of this baton, as stipulated previously, the presence of a
conflict of interest does not mean that regulatory activity will
necessarily reflect bias, negligence or lack of diligence on the part of
the next group of regulators: Each department’s work deserves to be
judged on its own merits. But in light of what appears to be a clear
pattern of bias in the prelicensure activities of DHHS, it’s reasonable
to approach an assessment of postlicensure activities with some
skepticism. What, then, does the public record of postlicensure
surveillance activity say about the presence of absence of bias and how
VSB and ISO have done their jobs in assessing Gardasil’s safety?

The main public output of the FDA and CDC groups’ work has so far
come in a single report published in the August 19, 2009 issue of the
Journal of the American Medical Association (JAMA). In that
paper, ISO’s Barbara Slade and four of her colleagues from CDC joined
together with seven FDA colleagues to publish the first-ever analysis of
the VAERS data on Gardasil. Not surprisingly, the JAMA paper gave
Gardasil a free pass; in the process the authors joined the chorus of
DHHS celebration for the breakthrough of its home-grown anti-cancer
vaccine. “Vaccination with [Gardasil] has the potential to decrease the
global morbidity and mortality of HPV-associated diseases, including
cervical cancer. After hepatitis B vaccine, which can prevent liver
cancer, [Gardasil] is only the second vaccine licensed with an
indication to prevent cancer.” And although they acknowledged the
possibility of injury due to blood clots like those that killed Brooke
Petkevicius, Slade et al argued that the data from VAERS led to the same
conclusion as the positive review from their colleagues at CBER. “The
postlicensure safety profile presented here is broadly consistent with
safety data from prelicensure trials.”

As for the specific question of Gardasil deaths, Slade et al
acknowledged that there had been deaths associated with Gardasil. But
they dismissed the VAERS death reports as not frequent enough to worry
about.

Criticism of the JAMA analysis came quickly (some preceded the
paper’s publication) and from several different quarters. One of the
most trenchant attacked the relevance of the VAERS case data itself and
came from the parents of a Gardasil victim. Like so many parents of
vaccine injured children, Jennifer Tetlock’s parents had become deeply
dissatisfied by the diligence of federal officials in evaluating
Gardasil’s safety. Jennifer’s adverse reaction, as originally diagnosed,
was among the least common adverse events; Slade et al reported it as an
isolated case. But in April 2009, Jenny’s parents publicly voiced their
suspicion that their doctor’s original diagnosis of juvenile amyotrophic
lateral sclerosis may have been misleadingly narrow. They argued that
“world-class immunologists suspect that Jenny had a potentially
treatable autoimmune disorder mimicking ALS, possibly triggered by the
Gardasil vaccination.” If true, this interpretation of her reaction
placed Jenny’s death in a broader category of a severe autoimmune
reactions from Gardasil. As reported previously in part 2, this kind of
autoimmune reaction was a risk that the clinical trials showed to be
quite common.

More broadly, Jenny’s parents struck out at CDC’s failure of
postlicensure diligence.

The CDC does not inspire confidence, so we conducted our own
shoestring search to determine whether Jenny was alone. We created a
website (jenjensfamilyblogspot.com). Although this website has only
drawn 40,000 visitors, it has out-performed the federal government in
finding girls ominously similar to Jenny (current score is: Jenny site
2; CDC’s VAERS: 0).

One does not need to be a statistician to see how unlikely it is
that these two other girls are the only cases out there—or how
frightening it is that we already know of three documented cases of
girls (those two plus Jenny) who developed ALS within several months
after their vaccinations. After all, if the odds of ALS in teenaged
girls are 1 in 3 million and we found 3 in only 40,000, it is very
possible that many other of the 6 million girls vaccinated have already
developed severe neurological collapse, like Jenny.

Jenny’s parents may have been uncertain about the proper diagnosis of
Jenny’s reaction, but they were not alone in their criticism of the
statistics underlying the FDA/CDC analysis. In a December 2009 letter to
JAMA, Drs. Vicky Debold (Full disclosure: Debold is a director of the
Age of Autism sponsor SafeMinds) and Eric Hurwitz criticized the Slade
analysis. Debold and Hurwitz identified numerous flaws in the CDC/FDA
report, arguing that: a) cases of autoimmune diseases such as
Guillain-Barré syndrome were systematically underreported; b) the method
for obtaining background rates of disease could include vaccine injury
and were thus inappropriate to use in comparisons; and c) the
denominator for the case population used to generate the PRRs was
grossly overstated. On the last point, Debold and Hurwitz noted that
Slade et al had mistakenly used “total vaccine doses distributed” as the
denominator for disease rates instead of doses administered (or for
that matter the number of women receiving doses), a choice that
“systematically inflates the ratio’s denominator.”

Debold and Hurwitz noted the larger policy problem created by these
failures in postlicensure surveillance and by Slade et al’s low standard
of diligence. “Federal officials have cited this study as evidence that
[Gardasil] ‘is a safe and effective vaccine,’” they noted. “However, we
consider that conclusion to be unwarranted because the study draws
inferences from data likely to be systematically biased.”

Diane Harper, one of the researchers involved in the Gardasil trials,
agreed with Debold and Hurwitz. In an August 2009 interview with CBS
News reporter Sharyl Attkisson, she also criticized Slade et al, arguing
to Attkisson that “the risks of vaccination are underreported in Slade's
article, as they are based on a denominator of doses distributed from
Merck's warehouse. Up to a third of those doses may be in refrigerators
waiting to be dispensed as the autumn onslaught of vaccine messages is
sent home to parents the first day of school. Should the
denominator in Dr. Slade's work be adjusted to account for this, and
then divided by three for the number of women who would receive all
three doses, the incidence rate of serious adverse events increases up
to five fold" [emphasis added].

Harper also agreed with Jenny Tetlock’s parents’ suggestion that
Slade et al were understating the number of deaths in their risk
assessment, the numerator. Harper told Attkisson, "Parents and women
must know that deaths occurred. Not all deaths that have been reported
were represented in Dr. Slade's work, one-third of the death reports
were unavailable to the CDC, leaving the parents of the deceased
teenagers in despair that the CDC is ignoring the very rare but real
occurrences that need not have happened if parents were given
information stating that there are real, but small risks of death
surrounding the administration of Gardasil."

So how should one weigh the net impact of all these claims and
criticisms? Certainly, although there are serious health risks,
including death, associated with Gardasil, there are also potential
benefits, including reduced rates of cervical cancer. Slade’s analysis
doesn’t provide the number of individuals receiving vaccine in the first
two years after the Merck vaccine’s introduction, but based on the
statistics she provides, it’s reasonable to assume that something less
than 10 million young women received doses of Gardasil (23 million doses
distributed with a target of 3 doses per subject). A balanced review of
the overall benefits of Gardasil would compare the frequency and
consequences of vaccine injury in this population, based on the most
objective rate of adverse events, with the vaccine’s purported benefits.

If we compare the death rate (these rates were calculated in part 2
of this series) in the Gardasil trial group of 8.5 per 10,000 to an
expected death rate in young women of 3.9 per 10,000, we get an extra
death risk from Gardasil of roughly 4-5 per 10,000 annually. Applied to
a population of 4 million young women per year, that would come to a
total of close to 2,000 extra deaths per year that were caused by
Gardasil during the period of its launch. This is an extraordinarily
high rate and may possibly be explained away by bad luck and
coincidences, as the CBER review contended. But it is the only active
surveillance analysis ever done on a population exposed to Gardasil. By
contrast, the calculated death rate from VAERS reports gives a much
lower number, over 100 times lower, a ratio that many consumer advocates
(and certainly Jennifer Tetlock’s parents) believe reflects more on the
poor quality of the VAERS database than the actual risk of death from
Gardasil.

But if Gardasil is successful in preventing deaths from cervical
cancer, is it possible that society is still coming out ahead overall?
The America Cancer Society estimates that there were 4,000 deaths in
2009 from cervical cancer. If Gardasil could prevent a significant
number of these deaths in the future, then it’s possible that the
benefits of the vaccine might exceed the risks. Unfortunately for the
vaccine program, the deaths caused by Gardasil are immediate and the
preventable deaths from cervical cancer are many years away.

Unfortunately for the public, in assessing the reliability of any
estimates of Gardasil’s future benefits there are many unknowns: we
don’t know how long the immunity against HPV will last; we don’t know
whether costly booster shots and a new round of adverse events will be
necessary; and, most important of all, we don’t yet have any idea
whether or not Gardasil will succeed in preventing a meaningful number
of cervical cancer deaths. We know it provides effective immunity
against two of the most common cancer-causing strains of HPV. But it’s
entirely possible that, just as soon Gardasil suppresses these strains
of HPV, new cancerous strains will arise to take their place leaving
overall cervical cancer rates unchanged. The dirty little secret of the
war on cervical cancer is that public health officials have no current
way to judge how and whether widespread vaccination with Gardasil will
affect the actual rate of cervical cancer and they won’t be able to make
that judgment for many years.

A similar situation holds in the case of a similarly multi-strain
infection and its associated vaccine formulation: in this case the many
different strains of streptococcus pneumoniae, the bacterial
species responsible for invasive pneumoccoal disease (or IPD) and the
so-called pneumococcal vaccine. In order to combat IPD, a leading cause
of bacterial meningitis, a multi-strain vaccine called Prevnar was
introduced by Wyeth in 2000. Prevnar quickly became one of the most
commercially successful vaccines of all time, bringing in nearly $3
billion in revenue in 2008. But in asking whether Gardasil will actually
work against cervical cancer, it’s useful to ask whether a similar
vaccine product like Prevnar has been successful in actually preventing
IPD?

A recent study from Massachusetts on its effectiveness suggests that
Prevnar, contrary to all expectations, did not reduce the incidence of
IPD in the state. Instead, although the forms of IPD caused by strains
in the vaccine went down after Prevnar’s introduction, IPD cases caused
by other strains (some of which were even more dangerous than the
original strains) rose almost immediately and in opposite proportions,
to keep the rate of IPD in Massachusetts constant. In plain language,
Prevnar, the most commercially valuable vaccine in history, created no
health benefits whatsoever. It just didn’t work.

Will this be the case with Gardasil? We will only know with any
certainty what Gardasil’s benefits will be after many years, even
decades of use. Right now, it’s too early to tell how many of the 4,000
annual deaths from cervical cancer might be prevented. But several
things are clear in the near term: Gardasil has already injured an
unknown number of young women, with these injuries likely including
deaths that may number in the hundreds, possibly (based on the only data
available) as many as 2,000 per year; Gardasil also has left many more
young women with crippling chronic conditions like Guillain-Barré
syndrome, arthritis and autoimmune thyroid conditions.

Diane Harper has also argued that assessments of the net benefits of
Gardasil have overstated its value. She told Sharyl Attkisson in her
interview that, "the risks of serious adverse events including death
reported after Gardasil use in the JAMA article by CDC’s Dr. Barbara
Slade were 3.4/100,000 doses distributed.” This rate is substantially
lower than our estimates here. Nevertheless, Harper remained concerned
that Gardasil’s risks outweighed its benefits. “The rate of serious
adverse events is on par with the death rate of cervical cancer.
Gardasil has been associated with at least as many serious adverse
events as there are deaths from cervical cancer developing each year.”

In light of the many years required to prevent cases of cervical
cancer, it’s clear that the current cost of Gardasil outweighs its
current benefit. Moreover, it may take many years to realize any net
benefit to society from Gardasil; the crossover point where realized
benefits exceed the costs incurred is far away and uncertain. At the
moment, therefore, there is only one net benefit that is certain: the
benefit to Merck’s bottom line. And, of course, the bottom line of
Merck’s business partner at NIH.

DHHS has a clear conflict of interest with respect to Gardasil at the
institutional level since it shares directly in Gardasil’s profits.
We’ve also seen now that this conflict of interest is echoed by (and
possibly sustains) a pervasive pattern of regulatory bias in favor of
Gardasil during multiple stages of the decision process. But as the
Gardasil body count rises, one natural question one might ask is why, at
a personal level, more DHHS officials haven’t taken the principled stand
of Diane Harper, who spoke up against the ACIP Gardasil recommendation
because “I want to be able to sleep with myself when I go to bed at
night.”

In the case of several senior officials involved in overseeing key
DHHS decisions during the Gardasil era, some portion of that answer is
provided by their subsequent career moves. Indeed, these moves reveal a
cultural problem that is in many ways more troubling than the direct
Gardasil financial conflicts: a pervasive pattern of senior officials
cashing in on their careers in public service in order to obtain
lucrative corporate and consulting jobs. The career moves of these
senior officials show that a virtual revolving door between regulators
and the pharmaceutical, vaccine and biologics companies they are
supposed to regulate erodes any meaningful sense in which these
officials truly serve consumer interests, especially when it comes to
product safety. This revolving door provides the cultural foundation
that undergirds some of the more egregious institutional conflicts.

A short account of the recent careers of just a few of the officials
involved in regulating Gardasil shows this revolving door in action.

• Mike Leavitt was named on December 13, 2004 as Secretary of DHHS,
where he subsequently was responsible most of the critical regulatory
decisions involving Gardasil. In January 2009, he left HHS and formed
Leavitt Partners, a Washington DC consulting firm that helps its client
“enter new markets, enhance the value of their products and navigate
dynamic regulatory and reimbursement systems.” In his consulting work,
Leavitt could certainly teach his clients about Gardasil and how they
could follow Merck’s example in forging a model “public-private
partnership.”

• Julie Gerberding was named Director of CDC on July 3, 2002 and served
in that role until she resigned on January 29, 2009. Gerberding watched
over Gardasil policy at CDC during the period of FDA review in which
ACIP put Gardasil on a fast track for approval in June 2006. She also
was in charge of the oversight for CDC’s postlicensure safety activities
during much of the period leading up to Slade et al’s JAMA submission
when portions of the VAERS analysis were reviewed with ACIP. Less than a
year after leaving public service, on December 21, 2009, Merck announced
Gerberding’s appointment as President of the Merck Vaccine Division,
effective January 25, 2010, the minimum interval allowed for a Federal
official to assume a position at a company they used to regulate.
Gerberding, who once regulated Gardasil, is now directly responsible for
its growth and profitability.

• Karen Goldenthal was the Director of the Division of Vaccines and
Related Products Applications within CBER, the FDA division responsible
for approving Gardasil’s BLA in June 2006. In 2007, shortly after
Gardasil’s approval, Goldenthal left CBER to become Executive Director
of PharmaNet Consulting. PharmaNet is “a global, drug development
services company, provides a comprehensive range of services to the
pharmaceutical, biotechnology, generic drug, and medical device
industries.” Other FDA executives have taken leadership positions at
PharmaNet, including William Egan, former head of Vaccine Research and
Review at FDA, now a Vice President in PharmaNet’s consulting practice.

These departures provide just a few small examples of a pervasive
exodus of FDA officials, many of whom leave FDA in order to provide
advice to pharmaceutical companies on how to make their way successfully
through the pre- and post-licensure processes. And when it comes to
vaccines, there is a specific market for former CBER officials to coach
vaccine manufacturers on how to get their BLAs approved and their
launches more profitable. Like PharmaNet, a consulting company called
the Biologics Consulting Group (BCG) shows how active the revolving door
between FDA and industry has become. Here’s how BCG describes itself.

Biologics Consulting Group, Inc. (BCG) is a team of consultants
who provide national and international regulatory and product
development advice on the development and commercial production of
biological, drug and device products. Our staff consists of experts in
regulatory affairs, product manufacturing and testing,
pharmacology/toxicology, facility inspections, statistics, program
management, and clinical trial design and evaluation. Many of
our consultants are former CBER, CDER, and CDRH reviewers. [emphasis
added]

In an environment so stepped in both direct and indirect conflicts of
interest, is it any wonder that Gardasil regulators have leaned so
steeply in favor of industry while overlooking serious safety concerns?

The final phase of regulatory activities surrounding Gardasil have
yet to play themselves out. These involve the process of adjudicating
claims of injury and death due to the vaccine. The DHHS agency
responsible for this work is the Health Resources Services Agency (HRSA),
which houses the Division of Vaccine Injury Compensation, the group
responsible for managing the Vaccine Injury Compensation Program (VICP),
more commonly known as “vaccine court.” In light of the pattern of bias
we’ve observed in the approach other DHHS agencies have taken to
Gardasil, one might reasonably question the prospects for fair treatment
of Gardasil victims in vaccine court. Can we really expect the director
of HRSA to encourage a fair and generous compensation policy on Gardasil
when her colleagues over at NIH are profiting from the patent license,
CDC is actively promoting its use and her former colleagues at FDA are
providing consulting services to companies helping them avoid regulatory
pitfalls and keep their profits intact?

As in the case of its sister agencies, the presence of conflict of
interest does not necessarily mean that HRSA will demonstrate bias,
negligence or failures of diligence in their approach to Gardasil. In
advance of any record of decisions, however, it’s simply too early to
tell how HRSA will respond. In other controversial areas such as the
Autism Omnibus Proceeding, petitioners have been deeply disappointed in
their treatment at the hands of the vaccine court. And it seems likely
that Gardasil families are destined for their own day in vaccine court:
HRSA provides “table injuries” that provide compensation for a short
list of outcomes on a few vaccines, but there are no table injuries yet
specified for Gardasil. (HRSA has commissioned the Institute of Medicine
to develop such a list for the entire category of HPV vaccines. A
candidate list of injuries can be found in the latest working list from
the “Committee to Review Adverse Events of Vaccines”, see
HERE ) So as Gardasil petitioners find their way into the VICP
process, HRSA officials will be setting Gardasil injury compensation
policy for the first time.

And the Gardasil girls are coming to seek justice. In an early
action, on March 13, 2010, the parents of Jennifer Tetlock filed the
following petition with the VICP.

The above captioned Petitioners request compensation under the
National Vaccine Injury Compensation Program, 42 U.S.C. 300aa-10 et seq.
(Supp. 1996), for the death of minor, Jennifer Tetlock who received the
third series of the Gardasil vaccination on March 1, 2007 from James
Cuthbertson, M.D. in Berkeley, California and thereafter suffered from
atypical amyotrophic lateral sclerosis (ALS)-like lower motor neuron
disease which was caused in fact by the above stated vaccination.

Will Jennifer Tetlock receive justice? It’s hard to imagine how any
agency so inextricably linked to the Gardasil program--from invention to
approval and recommendation to protection and profit—can possibly be
trusted to be a fair arbiter of guilt and innocence.

But one can always hope. After all, the guardians of vaccine safety
in DHHS have children themselves. And like Diane Harper, they also need
to sleep with themselves when they go to bed at night.